Novo’s semaglutide cuts CV events in diabetes, with 2016 filing on the horizon

Novo Nordisk ($NVO) has shown that its once-weekly experimental injectable diabetes med semaglutide can cut a number of cardiovascular events by 26% in Type 2 diabetes patients as it preps for both FDA and EMA filings.

The Danish diabetes specialist posted detailed data this morning showing its semaglutide--an investigational glucagon-like peptide-1 (GLP-1) analogue--significantly reduced the risk of cardiovascular (CV) death, nonfatal heart attack or nonfatal stroke by 26% when compared against a dummy treatment (and when added to standard of care), in more than 3,000 patients with Type 2 diabetes at a high CV risk.

The main results from SUSTAIN 6 were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD), as well as in the NEJM.

The data also showed a significant 39% decrease in nonfatal stroke alongside a nonsignificant 26% decrease in nonfatal myocardial infarction, as well as a neutral outcome (2% decrease) in CV death after two years of treatment. It has also previously posted strong data showing it can reduce blood sugar levels in diabetes patients.

“The reduction in cardiovascular events observed with semaglutide in SUSTAIN 6 is notable given the small study population and the short trial duration,” said Dr Steven Marso, SUSTAIN 6 investigator and the lead author for the New England Journal of Medicine publication.

“These findings are clinically relevant, as cardiovascular disease is the leading cause of death in people with Type 2 diabetes and new treatment options that can also reduce the risk of cardiovascular events are needed.”

There was a blotch on the data however, with significantly more people treated with semaglutide (50, or 3%) versus placebo (29, or 1.8%) suffering with diabetic retinopathy complications. The most common cause for patients dropping out of the trial was GI problems.

Sydbank analyst Soren Lontoft, as quoted by news wire Reuters, said: “These strong data suggest Novo will launch a bigger and longer cardiovascular impact study for semaglutide in order to show long-term benefits.”

It follows positive CV data already posted by its marketed GLP-1 blockbuster med Victoza (liraglutide [rDNA origin] injection), which showed in new figures published in June that it took a 13% bite out of the combined risk of heart attack, stroke and death from cardiovascular causes, among patients who came into the trial with established cardiovascular disease.

This follows on from positive CV data from Eli Lilly ($LLY) and Boehringer Ingelheim’s EMPA-REG outcomes trial, in which their SGLT-2 pill Jardiance reduced the MACE risk by 14% and cut CV death risk by 38%.

Novo’s drug is expected to bring in sales topping $2 billion at peak, and the company has said it plans to file its med in the U.S. and Europe in the final quarter.

Eli Lilly ($LLY) is however encroaching on Novo's GLP-1 territory, securing FDA approval in 2014 for the once-weekly Trulicity, the only contender that has measured up to Victoza in a Phase III trial.

Novo is however also working on an oral version of semaglutide, OG217SC, which recently notched a success in a Phase II trial.